Method and apparatus for occluding a blood vessel and/or for occluding other tubular structures and/or for closing openings in structures and/or for securing at least two objects together

ABSTRACT

Apparatus for occluding a space between a first structure and a second structure, said apparatus comprising:
         an occluder, said occluder comprising a distal implant and a proximal implant, wherein:
           said distal implant comprises a body and a locking shaft mounted to said body, wherein said body of said distal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the first structure, and further wherein said locking shaft comprises a first locking element for selective connection to said proximal implant and a second locking element for selective connection to an inserter for deploying said occluder; and   said proximal implant comprises a body having an opening, wherein said body of said proximal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the second structure, and further wherein said body of said proximal implant comprises a third locking element for selective connection to said first locking element of said distal implant;   wherein said locking shaft of said distal implant is slidably receivable within said opening in said body of said proximal implant, and further wherein said first locking element of said distal implant and said third locking element of said proximal implant are selectively engagable with one another so as to hold said distal implant and said proximal implant in fixed position relative to one another.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application:

(i) is a continuation-in-part of pending prior U.S. patent applicationSer. No. 13/857,424, filed Apr. 5, 2013 by Amsel Medical Corporation andArnold Miller et al. for METHOD AND APPARATUS FOR OCCLUDING A BLOODVESSEL (Attorney's Docket No. AM-9), which patent application (a) is acontinuation-in-part of prior U.S. patent application Ser. No.13/348,416, filed Jan. 11, 2012 by Arnold Miller et al. for METHOD ANDAPPARATUS FOR TREATING VARICOSE VEINS (Attorney's Docket No. AM-0708),which patent application claims benefit of prior U.S. Provisional PatentApplication Ser. No. 61/431,609, filed Jan. 11, 2011 by Arnold Millerfor METHOD AND APPARATUS FOR TREATING VARICOSE VEINS (Attorney's DocketNo. AM-7 PROV), and (b) claims benefit of prior U.S. Provisional PatentApplication Ser. No. 61/620,787, filed Apr. 5, 2012 by Arnold Miller etal. for TEMPORARY ARTERIAL OCCLUSION FOR MILITARY AND CIVILIAN EXTREMITYTRAUMA (Attorney's Docket No. AM-9 PROV); and

(ii) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 61/820,589, filed May 7, 2013 by Amsel Medical Corporation andArnold Miller for INJECTABLE CLAMPS FOR OCCLUSION OR ATTACHMENT(Attorney's Docket No. AM-15 PROV).

The five (5) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to surgical methods and apparatus in general, andmore particularly to surgical methods and apparatus for the occlusion ofblood vessels and the treatment of varicose veins, and/or for occludingother tubular structures and/or for closing openings in structuresand/or for securing at least two objects together. This invention alsorelates to a minimally invasive means for fastening mechanicalstructures to tissues or blood vessels, for example, for drug delivery.

BACKGROUND OF THE INVENTION Varicose Veins in General

There are three sets of veins in the legs: (i) superficial veins thatlie under the skin and may be seen and felt when standing; (ii) deepveins that lie within the muscles and are not seen or felt; and (iii)perforating or connecting veins that join the two systems (i.e., thesuperficial veins and the deep veins).

Veins lie within all tissues. Veins return blood to the heart. Whenmuscles in the leg contract, blood is pumped back to the heart. Valvesinside the veins direct the flow of blood back to the heart.

The veins are relatively weak tubes. Under the skin there is no supportfor these veins, so that when the pressure in the veins is elevated,areas of weakness occur and the veins enlarge, both in size and length.In some cases the veins can become twisty and bulge significantly. Thiscondition is commonly referred to as varicose veins.

Very small varicose veins are sometimes called spider veins. Unlike thelarger varicose veins, these spider veins lie in the skin.

The cause of the increased pressure in the veins is due to theoccurrence of “leaky” valves within the veins. The main valve is in thegroin region, i.e., in the great sapheous vein near the sapheno-femoraljunction. See FIG. 1, which shows a leg 5 of a patient, the femoral vein10, the great saphenous vein 15, the sapheno-femoral junction 20, andthe main valve 25 in the great saphenous vein near the sapheno-femoraljunction. Once this main valve in the saphenous vein becomes leaky, thepressure in the vein increases and the veins below the saphenous veinstart to enlarge. This causes the next set of valves in the saphenousvein to leak. The raised pressure caused by the leaky valves in thesaphenous vein is transmitted to the feeder veins, which distend andtheir valves also malfunction and become leaky. As this process carrieson down the leg, many of the valves in the leg veins become incompetent,with high pressures occurring in the veins, especially on standing.

Initially, the problem is primarily cosmetic. The veins bulge and lookunsightly. However, there is commonly also discomfort in the legs uponstanding. This discomfort is the result of the veins distending due tothe increased pressure.

With time, the high pressure in the veins is transmitted to thesurrounding tissues and skin. Small veins within the skin (i.e., spiderveins) enlarge and become visible. Blood cells may escape into thetissues and break down, causing areas of discoloration. Because thepressure in the tissues is high, the skin swells and the nutrition ofthe skin deteriorates. This lowers the local tissue resistance andallows infection to occur. Eventually skin may break down with thedevelopment of sores (i.e., ulcers).

Incidence of Varicose Veins

Nearly 40 percent of women and 25 percent of men suffer from lowerextremity venous insufficiency and associated visible varicose veins.Primary risk factors include heredity, gender, pregnancy and age. Mostof these patients have long-standing leg symptoms which compromise theirdaily routine, with symptoms worsening during the day while the patientsare at work or simply living their lives. Without varicose veintreatment, these symptoms can progress to a lifestyle-limitingcondition.

Treatment of Varicose Veins

Treatment of varicose veins is undertaken for relief of the symptoms,i.e., the removal of the unsightly veins and the prevention of thediscomfort and late-stage manifestations described above.

1. Non-Surgical Treatment.

The simplest treatment is a non-surgical treatment directed against thehigh pressure in the varicose veins. More particularly, fitted elasticstockings, strong enough to overcome the increased pressure caused bythe “leaky” valves, are used. These fitted elastic stockings control thesymptoms and may prevent the veins from further enlargement, however,they are not curative. Good results require consistent, every-day use ofthe stockings.

2. Surgical/Interventional Treatment.

The aim of the surgical/interventional treatment is (i) the eliminationof the cause of the high venous pressure (i.e., the “leaky” valves atthe groin); and (ii) the removal of the unsightly veins.

The early approach of “stripping” the saphenous vein (the main vein inthe leg) as the sole manner of treatment has now been largely abandoned.This is because the “stripping” approach caused too much trauma and didnot remove all of the superficial varicose veins: many of thesuperficial varicose veins were tributaries of the main superficial veinof the leg (i.e., the saphenous vein) that was stripped, and thesetributary veins were not removed by this procedure.

There are currently three basic approaches for treating varicose veins:chemical—sclerorosants and glues; venous ablation using thermaltreatments; and open surgery.

A. Sclerotherapy.

Sclerotherapy (the use of sclerosants) is generally used for treatingthe smaller varicose veins and spider veins that do not appear to bedirectly associated with “leaky” valves. It is primarily a cosmeticprocedure.

In this approach, a sclerosant (i.e., a substance irritating to thetissues) is injected into the smaller varicose veins and spider veins,causing inflammation of the walls of these veins. As a result of thisinflammation, the walls of the vein stick together and occlude the lumenof the vein so that no blood can pass through the vein. Eventually theseveins shrink and disappear.

The disadvantages of sclerotherapy include: (i) in the presence of highvenous pressure (i.e., with leaky valves and the larger varicose veins),the results are uncertain and the recurrence rate is high; and (ii) theerroneous injection of the sclerosant into the surrounding tissues canresult in damage to the surrounding tissues, with areas of discolorationof the skin and even ulceration.

Recently, mixing the sclerosant with air to form a “foam” has been usedto destroy the lining of the main vein (i.e., the saphenous vein) of theleg. To date, the results are somewhat unpredictable and there is adanger of the sclerosant escaping through the saphenous vein and intothe deep veins and then embolizing into the lungs, which is harmful anddangerous for the patient.

B. Venous Ablation.

Venous ablation for varicose veins can be effected in two ways, i.e.percutaneously and endovenously.

With the percutaneous approach, the superficial smaller varicose veinsand spider veins are “heated” and coagulated by shining an externallaser light through the skin. However, if the veins are too large, theamount of energy needed to destroy the veins may result in damage to thesurrounding tissues. Percutaneous laser treatment is primarily analternative to the sclerotherapy discussed above, and generally suffersfrom the same disadvantages described above with respect tosclerotherapy.

With endovenous ablation, a special laser or radio-frequency (RF)catheter is introduced, with local anesthesia, through a needle punctureinto the main superficial vein (i.e., the saphenous vein) of the leg.Entry is made in the region around the knee, and the catheter is passedup towards the groin, advancing to the site where the saphenous veinjoins the deep veins at the site of the main “leaky” valves. Then, asthe catheter is slowly withdrawn back through the vein, the laser lightor radio-frequency (RF) energy heats up the wall of the vein,endoluminally coagulating the proteins and destroying the lining surfaceof the vein. The destruction of the lining surface of the vein causesthe vein walls to adhere to one another, thereby eliminating the lumenwithin the vein and thus preventing the flow of blood. This is a processsomewhat similar to sclerotherapy, but no substance is injected into thevein. This procedure takes care of the “leaky” valves and high venouspressures, however, the larger superficial varicose veins in the leg maystill need to be removed. This may be done at the same time as theendovenous ablation or at a later time, either by open surgery(phlebectomy) or sclerotherapy. Placement of the laser orradio-frequency (RF) catheter is guided by ultrasound.

The advantages of endovenous laser/radio-frequency (RF) therapy include:(i) it is a minimally invasive procedure and can be done with localanesthesia, either in an operating room or a physician's office; (ii) itdoes not require hospitalization; (iii) it does not require open surgerywith incisions; (iv) recovery is easier than with open surgery, inasmuchas most patients are back at work within a day or two; and (v) some ofthe prominent varicosities may disappear and may not require a secondaryprocedure (i.e., either phlebectomy or sclerotherapy).

The disadvantages of endovenous laser/radio-frequency (RF) therapyinclude: (i) generally, only one leg is done at a time; (ii) theprocedure typically requires significant volumes of local anesthetic tobe injected into the patient in order to prevent the complications ofthe heat necessary to destroy the lining of the vein; (iii) if too muchheat is applied to the tissue, there can be burning in the overlyingskin, with possible disfiguring, including scarring; (iv) prior to theperformance of a subsequent phlebectomy procedure, an interval of up to8 weeks is required in order to evaluate the effectiveness of the venousablation procedure; and (v) varicosities that remain after this intervalprocedure still require separate procedures (i.e., phlebectomy orsclerothapy).

C. Open Surgery.

The aim of open surgery is to eliminate the “leaky” valve at thejunction of the superficial and deep veins (the cause of the high venouspressure in the leg), as well as the leaky valves in the tributaries ofthe saphenous vein that may enlarge over the years and result in arecurrence of the varicose veins. This open surgery is directed toremoval of some or all of the affected veins.

There is still some controversy as to how much of the saphenous veinneeds to be removed for the best results. The current “teaching” is thatremoving the entire segment of saphenous vein in the thigh reduces theincidence of recurrence. However, the data for this is very weak.Removal of a very short segment of the proximal saphenous vein and themain tributaries at the sapheno-femoral junction is the alternativeprocedure and, provided that it is combined with removal of all visiblevaricosities, the results are very similar to removal of the entirethigh segment of the saphenous vein. The advantage of the latterprocedure is the increased preservation of the saphenous vein which, in50-60% or more of varicose vein patients, is not involved in thevaricose vein process and is otherwise normal and hence usable for otherprocedures (such as a bypass graft in the heart or limbs).

The surgery is performed in the operating room under light general orregional (spinal or epidural) anesthesia. An incision (e.g., 1-2 inch)is made in the groin crease and the veins dissected out and the proximalsaphenous vein and tributaries excised. The wound is closed withabsorbable sutures from within. Once this is completed, small (e.g., 2-4mm) stab wounds are made over any unsightly varicose veins (these veinsare marked out just prior to the surgery with the patient standing) andthe varicose veins are completely removed. The small stab woundsassociated with removal of the marked-out veins are generally so smallthat they typically do not require any stitches to close them. When allthe previously marked-out veins are removed, the wounds are cleaned anda dressing applied. The leg is wrapped in elastic bandages (e.g., Acewraps).

In the post-operative care, the dressings and Ace wraps are usuallychanged in the doctor's office at the first post-operative visit,typically within 24 hours of the open surgical procedure. The patientand a family member or friend is instructed on proper care of thewounds. A simple dressing is applied to cover the small wounds in thelegs for the next 2-3 days. After 2-3 days no further treatment isgenerally required. Recovery is generally rapid, with the patientreturning to work within 5-7 days.

The advantages of open surgery include: (i) varicose veins of bothextremities can be done at a single operation, which generally takes 1-2hours; (ii) the procedure typically does not require hospitalization andis an “out patient” procedure; (iii) the wounds are minimal, withminimal discomfort which is easily managed with oral analgesics (i.e.,pain medicine); (iv) the results are generally excellent, with a minimumof recurrence (the results of open surgery remain the “gold standard”against which the sclerotherapy and laser/radio-frequency (RF) venousablation therapies are compared); (v) recurrent or residual (i.e., thosemissed at surgery) veins are generally managed with sclerotherapy orphlebectomy under local anesthesia in a doctor's office or in anambulatory procedure room; and (vi) the saphenous vein, if normal andwithout varicosities, is preserved and is therefore available for use(e.g., for bypass surgery) in the future if it should be needed.

The disadvantages of open surgery include: (i) it is an open surgicalprocedure requiring an anesthetic (either general or regional), with itsassociated discomfort and with its attendant risks (which may depend onthe health or age of the patient); and (ii) recovery generally takes 3-5days.

Thus it will be seen that varicose veins present a significant problemfor many patients which must be addressed, and all of the currentprocedures for treating varicose veins suffer from a number ofsignificant disadvantages.

Accordingly, it would be advantageous to provide new and improvedsurgical methods and apparatus for the occlusion of blood vessels andthe treatment of varicose veins, and/or for occluding other tubularstructures and/or for closing openings in structures and/or for securingat least two objects together.

It would also be advantageous to provide new and improved surgicalmethods and apparatus for fastening mechanical structures to tissues orblood vessels, for example, for drug delivery.

SUMMARY OF THE INVENTION

The present invention provides a new and improved approach for treatingvaricose veins and other blood vessels.

More particularly, the present invention comprises the provision and useof a novel occluder which is used to occlude a vein (e.g., the proximalsaphenous vein, the small saphenous vein, tributaries, the perforatorveins, etc.) so as to restrict blood flow through the vein and therebytreat varicose veins below the point of occlusion. Significantly, thenovel occluder is configured to be deployed using a minimally-invasiveapproach (i.e., either percutaneously or endoluminally), withvisualization being provided by ultrasound and/or other visualizationapparatus (e.g., CT, MRI, X-ray etc.). As a result, the novel treatmentcan be provided in a doctor's office, with minimal local anesthetic, andeffectively no post-operative care.

The present invention also provides new and improved surgical methodsand apparatus for occluding other tubular structures and/or for closingopenings in structures and/or for securing at least two objectstogether.

And the present invention provides new and improved surgical methods andapparatus for fastening mechanical structures to tissues or bloodvessels, for example, for drug delivery.

Significantly, the present invention may be practiced under directvisualization (e.g., during “open” surgery) or under indirectvisualization (e.g., during laparoscopic surgery where visualization isprovided through the use of a scope, or during percutaneous surgerywhere visualization is provided through the use of imaging apparatussuch as an ultrasound imager, an X-ray imager, etc.).

In one form of the invention, there is provided apparatus for occludinga blood vessel, the apparatus comprising:

an occluder, the occluder being configured so that at least a portion ofthe occluder may assume (i) a diametrically-reduced configuration fordisposition within the lumen of a tube, and (ii) adiametrically-expanded configuration for disposition adjacent to theblood vessel, such that when said at least a portion of the occluder isin its diametrically-expanded configuration adjacent to the bloodvessel, the occluder will cause occlusion of the blood vessel.

In another form of the invention, there is provided a method foroccluding a blood vessel, the method comprising:

providing apparatus comprising:

-   -   an occluder, the occluder being configured so that at least a        portion of the occluder may assume (i) a diametrically-reduced        configuration for disposition within the lumen of a tube,        and (ii) a diametrically-expanded configuration adjacent to the        blood vessel, such that when said at least a portion of the        occluder is in its diametrically-expanded configuration adjacent        to the blood vessel, the occluder will cause occlusion of the        blood vessel; and

positioning the occluder adjacent to the blood vessel so as to causeocclusion of the blood vessel.

In another form of the invention, there is provided apparatus fordelivering a substance to a location adjacent to a blood vessel, theapparatus comprising:

a carrier, the carrier being configured so that at least a portion ofthe carrier may assume (i) a diametrically-reduced configuration fordisposition within the lumen of a tube, and (ii) adiametrically-expanded configuration for disposition adjacent to theblood vessel, such that when the substance is attached to the carrierand said at least a portion of the carrier is in itsdiametrically-expanded configuration adjacent to the blood vessel, thesubstance will be disposed adjacent to the blood vessel.

In another form of the invention, there is provided a method fordelivering a substance to a location adjacent to a blood vessel, themethod comprising:

providing apparatus comprising:

-   -   a carrier, the carrier being configured so that at least a        portion of the carrier may assume (i) a diametrically-reduced        configuration for disposition within the lumen of a tube,        and (ii) a diametrically-expanded configuration for disposition        adjacent to the blood vessel, such that when the substance is        attached to the carrier and said at least a portion of the        carrier is in its diametrically-expanded configuration adjacent        to the blood vessel, the substance will be disposed adjacent to        the blood vessel; and

positioning the carrier adjacent to the blood vessel so that thesubstance is disposed adjacent to the blood vessel.

In another form of the invention, there is provided apparatus foroccluding a space between a first structure and a second structure, saidapparatus comprising:

an occluder, said occluder comprising a distal implant and a proximalimplant, wherein:

-   -   said distal implant comprises a body and a locking shaft mounted        to said body, wherein said body of said distal implant comprises        a plurality of legs which may assume (i) a diametrically-reduced        configuration for disposition within the lumen of a tube,        and (ii) a diametrically-expanded configuration for disposition        against the first structure, and further wherein said locking        shaft comprises a first locking element for selective connection        to said proximal implant and a second locking element for        selective connection to an inserter for deploying said occluder;        and    -   said proximal implant comprises a body having an opening,        wherein said body of said proximal implant comprises a plurality        of legs which may assume (i) a diametrically-reduced        configuration for disposition within the lumen of a tube,        and (ii) a diametrically-expanded configuration for disposition        against the second structure, and further wherein said body of        said proximal implant comprises a third locking element for        selective connection to said first locking element of said        distal implant;    -   wherein said locking shaft of said distal implant is slidably        receivable within said opening in said body of said proximal        implant, and further wherein said first locking element of said        distal implant and said third locking element of said proximal        implant are selectively engagable with one another so as to hold        said distal implant and said proximal implant in fixed position        relative to one another.

In another form of the invention, there is provided a method foroccluding a space between a first structure and a second structure, saidmethod comprising:

providing apparatus comprising:

-   -   an occluder, said occluder comprising a distal implant and a        proximal implant, wherein:        -   said distal implant comprises a body and a locking shaft            mounted to said body, wherein said body of said distal            implant comprises a plurality of legs which may assume (i) a            diametrically-reduced configuration for disposition within            the lumen of a tube, and (ii) a diametrically-expanded            configuration for disposition against the first structure,            and further wherein said locking shaft comprises a first            locking element for selective connection to said proximal            implant and a second locking element for selective            connection to an inserter for deploying said occluder; and        -   said proximal implant comprises a body having an opening,            wherein said body of said proximal implant comprises a            plurality of legs which may assume (i) a            diametrically-reduced configuration for disposition within            the lumen of a tube, and (ii) a diametrically-expanded            configuration for disposition against the second structure,            and further wherein said body of said proximal implant            comprises a third locking element for selective connection            to said first locking element of said distal implant;    -   wherein said locking shaft of said distal implant is slidably        receivable within said opening in said body of said proximal        implant, and further wherein said first locking element of said        distal implant and said third locking element of said proximal        implant are selectively engagable with one another so as to hold        said distal implant and said proximal implant in fixed position        relative to one another; and

positioning said occluder so that said plurality of legs of said distalimplant are disposed against the first structure, said plurality of legsof said proximal implant are disposed against the second structure, andsaid locking shaft extends across the space between the first structureand the second structure.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing various aspects of the venous systemof the leg;

FIGS. 2-4 are schematic views showing an occluder occluding a bloodvessel in accordance with one form of the present invention;

FIG. 5 is a schematic view showing one possible construction for theoccluder shown in FIGS. 2-4;

FIGS. 6 and 7 are schematic views showing an exemplary syringe-typeinserter which may be used to deploy the occluder shown in FIGS. 2-4;

FIGS. 8-10 are schematic views showing an occluder occluding a bloodvessel in accordance with another form of the present invention;

FIGS. 11-14 are schematic views showing an occluder occluding a bloodvessel in accordance with still another form of the present invention;

FIGS. 15-17 are schematic views showing other possible constructions forthe occluder of the present invention;

FIGS. 18-20 are schematic views showing the occluders of the types shownin FIGS. 15-17 occluding a blood vessel in accordance with yet anotherform of the present invention;

FIGS. 21-24 are schematic views showing an occluder occluding a bloodvessel in accordance with another form of the present invention;

FIGS. 25-27 are schematic views showing an occluder occluding a bloodvessel in accordance with still another form of the present invention;

FIGS. 28 and 29 are schematic views showing an occluder occluding ablood vessel in accordance with yet another form of the presentinvention;

FIGS. 30 and 31 are schematic views showing an occluder occluding ablood vessel in accordance with another form of the present invention;

FIGS. 32 and 33 are schematic views showing an occluder occluding ablood vessel in accordance with still another form of the presentinvention;

FIGS. 34 and 35 are schematic views showing a drug/cellular deliverybody being attached to a blood vessel in accordance with one form of thepresent invention;

FIGS. 36 and 37 are schematic views showing a drug/cellular deliverybody being attached to a blood vessel in accordance with another form ofthe present invention;

FIGS. 38 and 39 are schematic views showing a drug/cellular deliverybody being attached to a blood vessel in accordance with still anotherform of the present invention;

FIGS. 40 and 41 are schematic views showing a drug/cellular deliverybody being attached to a blood vessel in accordance with yet anotherform of the present invention;

FIGS. 42-48 are schematic views showing a two-part occluder formed inaccordance with another form of the present invention;

FIGS. 49-58 are schematic views showing installation apparatus which maybe used to deploy the two-part occluder of FIGS. 42-48;

FIGS. 59-82 are schematic views showing the two-part occluder of FIGS.42-48 being deployed across a blood vessel using the installationapparatus of FIGS. 49-58;

FIGS. 83-86 are schematic views showing another two-part occluder formedin accordance with the present invention;

FIGS. 87-90 are schematic views showing still another two-part occluderformed in accordance with the present invention;

FIGS. 91-94 are schematic views showing yet another two-part occluderformed in accordance with the present invention;

FIGS. 95-100 are schematic views showing another two-part occluderformed in accordance with the present invention;

FIGS. 101-104 are schematic views showing another two-part occluderformed in accordance with the present invention;

FIGS. 105-113 are schematic views showing an installation apparatus fordeploying the two-part occluder shown in FIGS. 101-104;

FIGS. 114-120 are schematic views showing another installation apparatusfor deploying the two-part occluder shown in FIGS. 101-104;

FIGS. 121-123 are schematic views showing another two-part occluderformed in accordance with the present invention;

FIGS. 124-126 are schematic views showing means for securing thetwo-part occluder shown in FIGS. 121-123 to an installation apparatus;

FIG. 127 is a schematic view showing another two-part occluder formed inaccordance with the present invention;

FIGS. 128-133 are schematic views showing a placement device forfacilitating proper placement of an occluder so as to occlude a bloodvessel (or other hollow tubular body);

FIG. 134 is a schematic view showing a tool for lifting a blood vessel(or other hollow tubular body) away from an underlying anatomicalstructure so as to facilitate proper placement of an occluder; and

FIGS. 135-137 are schematic views showing use of an occluder for closingoff an organ.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a new and improved approach for treatingvaricose veins and other blood vessels.

More particularly, the present invention comprises the provision and useof a novel occluder which is used to occlude a vein (e.g., the proximalsaphenous vein, the small saphenous vein, tributaries, the perforatorveins, etc.) so as to restrict blood flow through the vein and therebytreat varicose veins below the point of occlusion. Significantly, thenovel occluder is configured to be deployed using a minimally-invasiveapproach (i.e., either percutaneously or endoluminally), withvisualization being provided by ultrasound and/or other visualizationapparatus (e.g., CT, MRI, X-ray etc.). As a result, the novel treatmentcan be provided in a doctor's office, with minimal local anesthetic, andeffectively no post-operative care.

The present invention also provides new and improved surgical methodsand apparatus for occluding other tubular structures and/or for closingopenings in structures and/or for securing at least two objectstogether.

And the present invention provides new and improved surgical methods andapparatus for fastening mechanical structures to tissues or bloodvessels, for example, for drug delivery.

Percutaneous Approach

In the percutaneous approach, the occluder is delivered bypercutaneously advancing the occluder through the skin, throughintervening tissue and then across some or all of the blood vessel(e.g., the great saphenous vein near the sapheno-femoral junction) so asto occlude the blood vessel. This occlusion (or multiple of theseocclusions) will thereby treat varicose veins. In one form of theinvention, the occluder is configured to occlude the vein by compressingthe vein and closing down its lumen; and in another form of theinvention, the occluder is configured to occlude the vein by depositinga mass within the lumen of the vein so as restrict blood flow throughthe lumen of the vein. The occlusion of the lumen may be complete orpartial. If the occlusion is partial, some blood may continue to flow inthe vein. Such partial occlusion can act to relieve some of the pressureon the valve, thereby improving its function. In some applications, anocclusion of 70% or greater of the lumen may be desired and realizedbased on the current invention. In other applications, an occlusion of80% or greater of the lumen may be desired and realized based on thecurrent invention. In one embodiment, the occlusion pressure applied maybe greater than 40 mm of mercury. In another embodiment of the presentinvention, the occlusion pressure may be greater than the pressure ofthe typical blood flow in the vein.

Looking first at FIGS. 2-4, in one form of the invention, there isprovided an occluder 30. Occluder 30 comprises an elastic filament 35which, in an unconstrained condition, comprises a generally non-linearconfiguration (e.g., a coiled mass) but which, when properly restrained,can maintain a linear configuration (e.g., in the narrow lumen 40 of aneedle 45, or where the filament is formed out of a shape memorymaterial, by appropriately controlling its temperature and hence itsshape); when the restraint is removed (e.g., the elastic filament 35 isextruded from the constraining lumen 40 of the needle 45, or thetemperature of the shape memory material is elevated such as by bodyheat), elastic filament 35 will return to its generally non-linearconfiguration, whereby to provide enlarged masses for occluding thevein.

In one form of the invention, the occluder is formed out of a shapememory material (e.g., a shape memory alloy such as Nitinol, or a shapememory polymer), with the shape memory material being configured toprovide superelasticity, or temperature-induced shape changes, or both).

In one preferred method of use, the occluder 30 is installed in thenarrow lumen 40 of a needle 45 (FIG. 2), the needle is introducedpercutaneously and advanced across the vein which is to be occluded(e.g., the great saphenous vein 15), a first length of the occluder isextruded from the needle on the far side of the vein so that a portionof the occluder is restored to a coiled mass configuration 50 on the farside of the vein (FIG. 3), the needle is withdrawn back across the vein,and then the remainder of the occluder is extruded on the near side ofthe vein (FIG. 4), whereupon the remainder of the occluder is restoredto a coiled mass configuration 55, with a portion 57 of the occluderextending across the lumen 60 of the vein 15, and with the portions ofthe occluder on the far and near sides of the vein (i.e., the coiledmasses 50 and 55, respectively) being drawn toward one another under thecoiling force inherent in the elastic filament so as to compress thevein there between and occlude its lumen 60, whereby to restrict bloodflow through the vein and thereby treat the varicose veins.

As noted above, occluder 30 may be formed out of a shape memory material(e.g., a shape memory alloy such as Nitinol, or a shape memory polymer,etc.), with the shape memory material being configured to providesuperelasticity, or temperature-induced shape changes, or both).

In the form of the invention shown in FIGS. 2-4, occluder 30 is formedout of a single elastic filament 35, and a shape transition (i.e., fromsubstantially linear to a pair of opposing coiled masses 50, 55) is usedto cause occlusion of the target blood vessel. In this respect it shouldbe appreciated that the aforementioned coiled masses 50, 55 may comprisesubstantially random turns of the elastic filament arranged in asubstantially three-dimensional structure (i.e., somewhat analogous to aball of string), or the coiled masses 50, 55 may comprise highlyreproducible structures such as loops, coils, etc., and these loops,coils, etc. may or may not assume a substantially planar structure. See,for example, FIG. 5, where coiled masses 50, 55 comprise highlyreproducible loops and coils.

FIGS. 6 and 7 show an exemplary syringe-type inserter 65 which may beused to deploy the novel occluder of the present invention. Thesyringe-type inserter 65 may contain one occluder 30 or multiplepre-loaded occluders 30, e.g., where syringe-type inserter 65 comprisesmultiple occluders 30, the occluders may be disposed serially within thesyringe-type inserter, or they may be disposed parallel to one anotherwithin the syringe-type inserter (i.e., in the manner of a “Gatling gun”disposition), etc. When the syringe-type inserter 65 is activated, anoccluder 30 is deployed out of the distal end of needle 45.

In FIGS. 2-4, occluder 30 is shown occluding the vein by compressing thevein between the two coiled masses 50, 55, whereby to close down itslumen 60. However, in another form of the invention, the occluder 30 canbe used to occlude the vein without compressing the vein. This is doneby depositing a coiled mass within the lumen of the vein, whereby torestrict blood flow through the lumen of the vein. More particularly,and looking now at FIGS. 8-10, in this form of the invention, the needle45 is passed into the interior of the vein 15 and one coiled mass 50 ofthe occluder 30 is extruded into the lumen 60 of the vein (FIG. 8) so asto occlude the lumen of the vein, the needle 45 is withdrawn to the nearside of the vein (FIG. 9), and then another coiled mass 55 is disposedon the near side of the vein (FIG. 10), with the portion 57 of theoccluder extending through the side wall of the vein so as to stabilizethe occluder relative to the vein (i.e., so as to attach the occluder tothe vein and prevent the occluder from moving relative to the vein).

FIGS. 11-14 show another approach where a coiled mass of the occluder 30is deposited within the interior of the blood vessel so as to obstructblood flow through the vessel. More particularly, in this form of theinvention, the needle 45 is passed completely through the vein (FIG.11), a coiled mass 50 of the occluder is deposited on the far side ofthe vein (FIG. 12), the needle is withdrawn into the interior of thevein where another coiled mass 55 of the occluder is deposited (FIG.13), and then the needle is withdrawn to the near side of the vein whereanother coiled mass 70 of the occluder 30 is deposited (FIG. 14). Inthis form of the invention, coiled mass 55 resides within the lumen 60of the vein and obstructs blood flow while coiled masses 50 and 70compress the vein inwardly and stabilize the disposition of theintraluminal coiled mass 55.

FIGS. 15 and 16 show occluders 30 formed out of a single strand ofelastic filament. In FIG. 15, the occluder 30 comprises a relativelyordered coil where the turns 72 of the coil are unidirectional. In FIG.16, the occluder 30 comprises another relatively ordered coil but wherethe turns rotate in opposite directions on different sides of a midpoint75. Of course, it should also be appreciated that the occluder 30 can beconstructed so as to form a relatively disordered coil, i.e., where thestrand of the filament follows a relatively random pattern (see, forexample, the disordered coils illustrated in FIGS. 8-10). Indeed, whereit is desired that the mass of the reformed coil itself provide a flowobstruction (e.g., where the reformed coil is disposed intraluminally soas to impede blood flow through the vein), it is generally preferredthat the elastic filament reform into a relatively disordered coilhaving a relatively random disposition, since this can provide a denserfilament configuration.

FIG. 17 shows an occluder 30 formed out of multiple strands of elasticfilaments 35. In one form of the invention, these multiple strands arejoined together at a joinder 80. Again, the coils (e.g., theaforementioned coiled masses 50, 55, 70) formed by these multiplestrands can be relatively ordered or relatively disordered. FIGS. 18 and19 show how the multistrand occluder of FIG. 17 can be used to occlude avein by forming coiled masses 50, 55 to compress the side wall of thevein inwardly so as to restrict blood flow through the vein. FIG. 20shows how the multi-strand occluder 30 of FIG. 17 can be used to occludea vein by depositing a coiled mass 55 within the lumen 60 of the vein,whereby to restrict blood flow through the lumen of the vein. In FIG.20, a number of the elastic filaments 35 are shown piercing the sidewall of the vein so as to hold the coiled mass 55 in position within thelumen of the blood vessel.

FIGS. 21-24 show another form of occluder 30 where the occluder isformed by structures other than a filament. By way of example but notlimitation, the occluder 30 may comprise a transluminal section 85, afar side lateral projection 90 and a near side lateral projection 95,with the far side lateral projection 90 and the near side lateralprojection 95 being held in opposition to one another so as to closedown the lumen 60 of the vein 15. Such an arrangement may be provided bymany different types of structures, e.g., such as the “double T-bar”structure shown in FIGS. 25-27 where the transluminal section 85 of theoccluder 30 is formed out of an elastic material which draws the twoopposing T-bars 90, 95 of the occluder together so as to provide vesselocclusion. Still other arrangements for connecting and drawing togethera far side lateral projection 90 and a near side lateral projection 95will be apparent to those skilled in the art in view of the presentdisclosure. By way of further example but not limitation, far sidelateral projection 90 and near side lateral projection 95 may beconnected together by a loop of suture, with the loop of suture beinglockable in a reduced size configuration (i.e., so as to maintainocclusion) with a sliding locking knot.

Furthermore, multiple occluders 30 may be used on a single blood vesselor tissue to occlude the blood vessel more completely, or to occlude ablood vessel in multiple regions, or to attach a material (e.g., a drugor cellular delivery element) in multiple places to the blood vessel.The occluders may be coated with a drug-eluting compound, or theoccluders may be electrically charged to enhance or prevent clotting orto deliver a desired compound or agent to the blood vessel, etc. Ifdesired, the location of the occluding or attachment element may beprecisely controlled to deliver the desired compound or agent at aspecific anatomical location.

Endoluminal Approach

In the endoluminal approach, the occluder 30 is delivered to theocclusion site by endoluminally advancing the occluder up the vein usinga catheter, and then deploying the occluder in the vein, with theoccluder acting to occlude the vein and thereby treat varicose veins. Inthis form of the invention, the occluder is preferably passed throughone or more side walls of the vein so as to stabilize the occluderrelative to the vein. In one form of the invention, the occluder isconfigured to occlude the vein by depositing a mass within the lumen ofthe vein so as to restrict blood flow through the lumen of the vein; andin another form of the invention, the occluder is configured to occludethe vein by compressing the vein and closing down its lumen.

More particularly, and looking now at FIGS. 28 and 29, a catheter 100 isused to endoluminally advance the occluder 30 up the interior of thevein 15 to a deployment site. Then one end of the occluder is passedthrough the side wall of the vein so as to deposit a coiled mass 50 ofthe occluder 30 outside the vein, and the remainder of the occluder isdeposited as a coiled mass 55 within the lumen 60 of the vein, with aportion 57 of the occluder extending through the side wall of the veinso as to attach the occluder to the side wall of the vein and therebystabilize the occluder relative to the vein. Thus, in this form of theinvention, a coiled mass 55 of the occluder is deposited within theinterior of the vein so as to restrict blood flow through the vein andthereby treat varicose veins.

FIGS. 30 and 31 show how two separate occluders 30, each used in themanner shown in FIGS. 28 and 29, can be used to increase the coiled massof occluder contained within the lumen of the vein, whereby to increasethe extent of occlusion of the lumen of the vein.

FIGS. 32 and 33 show how an occluder 30 can be delivered endoluminallyand used to compress the outer walls of the vein so as to occlude bloodflow through the lumen of the vein. More particularly, in this form ofthe invention, the occluder 30 is advanced endoluminally through thevein to the deployment site, one end of the occluder is passed throughone side wall of the vein so as to deposit a coiled mass 50 on one sideof the vein and the other end of the occluder is passed through theother side wall of the vein so as to deposit another coiled mass 55 onthe other side of the vein, with the two coiled masses being connectedtogether by the intermediate portion 57 of the occluder and with the twocoiled masses being drawn toward one another under the coiling forceinherent in the elastic filament so as to apply compressive opposingforces on the two sides of the vein, whereby to compress the vein andclose down its lumen.

Occlusion in Combination with Phlebectomy

If desired, the novel occluder of the present invention can be used inconjunction with the removal of the large varicose veins (i.e.,phlebectomy). The phlebectomy can be done at the same time as theocclusion of the vein or at another time. For this surgical procedure,minimal local anesthetic is needed.

Occluding Tubular Structures for Purposes Other than Treating VaricoseVeins

It will be appreciated that the novel occluder of the present inventioncan also be used to occlude tubular structures for purposes other thantreating varicose veins. By way of example but not limitation, the noveloccluder of the present invention can be used to occlude other vascularstructures (e.g., to occlude arteries so as to control bleeding), or toocclude other tubular structures within the body (e.g., phallopiantubes, so as to induce infertility), etc.

Drug/Cellular Delivery Applications

Furthermore, using the foregoing concept of minimally-invasive hollowtube penetration, and attachment and fixation of the device to thevessel wall, either percutaneously or endoluminally, the occluder 30 maybe modified so as to allow drug/cellular delivery at fixed points withinor adjacent to the vasculature or other hollow bodily structure. In thisform of the invention, the device functions as a drug/cellular deliverystabilizer, and may or may not function as an occluder. See, forexample, FIGS. 34 and 35, where an elastic filament 35, having adrug/cellular delivery body 105 attached thereto, is advanced across ablood vessel 110 using a needle 115, with the distal end of the elasticfilament forming a coiled mass 120 on the far side of the blood vesseland the drug/cellular delivery body 105 being securely disposed withinthe lumen 125 of the blood vessel. FIGS. 36 and 37 show a similararrangement where a catheter 130 is used to deliver the deviceendoluminally. FIGS. 38 and 39 show another arrangement wherein thedevice is delivered percutaneously so that the coiled mass is disposedinside lumen 125 of the blood vessel and the drug/cellular delivery body105 is disposed outside the blood vessel, and FIGS. 40 and 41 show howthe device is delivered endoluminally so that the coiled mass isdisposed inside lumen 125 of the blood vessel and the drug/cellulardelivery body 105 is disposed outside the blood vessel. Thesedrug/cellular delivery devices may be passive or active polymers orsilicon-based or micro- and nanotechnology devices, or matrices ofmaterials, etc.

Two-Part Occluder

Looking next at FIG. 42, there is shown a two-part occluder 200 formedin accordance with the present invention. Two-part occluder 200generally comprises a distal implant 205 and a proximal implant 210.

Distal implant 205 is shown in further detail in FIGS. 43-46. Distalimplant 205 comprises a distal implant body 215 and a distal implantlocking tube 220. Distal implant body 215 comprises a tube 225 having adistal end 226, a proximal end 227, and a lumen 230 extendingtherebetween. Tube 225 is slit intermediate its length so as to define aplurality of legs 235. A set of inwardly-projecting tangs 240 are formedin tube 225 between legs 235 and proximal end 227. A set of windows 245are formed in tube 225 between inwardly-projecting tangs 240 andproximal end 227. Distal implant body 215 is preferably formed out of anelastic material (e.g., a shape memory material having superelasticproperties such as Nitinol or superelastic polymers, includingsuperelastic plastics) and constructed so that its legs 235 normallyproject laterally away from the longitudinal axis of tube 225 (e.g., inthe manner shown in FIGS. 43 and 44), however, due to the elastic natureof the material used to form distal implant body 215, legs 235 can beconstrained inwardly (e.g., within the lumen of a delivery needle, aswill hereinafter be discussed) so that distal implant body 215 canassume a substantially linear disposition. See, for example, FIG. 46,which shows legs 235 moved inwardly relative to the position shown inFIGS. 43 and 44. However, when any such constraint is removed, theelastic nature of the material used to form distal implant body 215causes legs 235 to return to the position shown in FIGS. 43 and 44.

Distal implant locking tube 220 (FIG. 45) comprises a generally tubularstructure having a distal end 250, a proximal end 260 and a lumen 262extending therebetween. A set of windows 265 are formed in the distalimplant locking tube 220, with windows 265 being disposed distal toproximal end 260.

Distal implant locking tube 220 is disposed within lumen 230 of distalimplant body 215. When distal implant 205 is in its aforementionedsubstantially linear condition (i.e., with legs 235 restrained in anin-line condition), distal implant locking tube 220 terminates wellshort of tangs 240 of distal implant body 215, so that the proximal end227 of distal implant body 215 can move longitudinally relative todistal end 226 of distal implant body 215. However, when the proximalend 227 of distal implant body 215 is moved distally a sufficientdistance to allow full radial expansion of legs 235 (see FIG. 42),locking tangs 240 of distal implant body 215 will be received withinwindows 265 of distal implant locking tube 220, whereby to lock distalimplant 205 in its radially-expanded condition (i.e., with legs 235projecting laterally away from the longitudinal axis of tube 225, e.g.,in the manner shown in FIGS. 43 and 44). Spot welds applied via openings270 formed in the distal end 226 of distal implant body 215 serve tolock distal implant locking tube 220 to distal implant body 215, wherebyto form a singular structure (see FIGS. 43 and 46).

Looking next at FIGS. 47 and 48, proximal implant 210 comprises a tube275 having a distal end 280, a proximal end 285, and a lumen 290extending therebetween. Tube 275 is slit at its distal end so as todefine a plurality of legs 295. A set of inwardly-projecting tangs 300are formed in tube 275 between legs 295 and proximal end 285. Proximalimplant 210 is preferably formed out of an elastic material (e.g., ashape memory material having superelastic properties such as Nitinol)and constructed so that its legs 295 normally project laterally awayfrom the longitudinal axis of tube 275 (e.g., in the manner shown inFIG. 47), however, legs 295 can be constrained inwardly (e.g., withinthe lumen of a delivery tube, as will hereinafter be discussed) so thatproximal implant 210 can assume a substantially linear disposition. See,for example, FIG. 48, which shows legs 295 moved inwardly relative tothe position shown in FIG. 47. However, when any such constraint isremoved, the elastic nature of the material used to form proximalimplant 210 causes legs 295 to return to the position shown in FIG. 47.

As will hereinafter be discussed, distal implant 205 and proximalimplant 210 are configured and sized so that tube 225 of distal implantbody 215 can be received in lumen 290 of proximal implant 210, with theexpanded legs 235 of distal implant 205 opposing the expanded legs 295of proximal implant 210 (see, for example, FIG. 82), whereby to impose aclamping action on the side wall of a blood vessel (e.g., vein) disposedtherebetween and thereby occlude the blood vessel, as will hereinafterbe discussed in further detail (or, as an alternative, the opposingexpanded legs of the proximal and distal implants could interdigitate toimpose the clamping action). Furthermore, distal implant 205 andproximal implant 210 are configured and sized so that they may be lockedin this position, inasmuch as inwardly-projecting tangs 300 of proximalimplant 210 will project into windows 245 of distal implant 205.

Two-part occluder 200 is intended to be deployed using associatedinstallation apparatus. This associated installation apparatuspreferably comprises a hollow needle 305 (FIG. 49) for penetratingtissue, a distal implant delivery tube 310 (FIG. 50) for deliveringdistal implant 205 through hollow needle 305 to the far side of theblood vessel which is to be occluded, a composite guidewire 315 (FIGS.51-56) for supplying support to various components during delivery anddeployment, a push rod 320 (FIG. 57) for delivering various componentsover composite guidewire 315, and a proximal implant delivery tube 330(FIG. 58) for delivering proximal implant 210 for mating with distalimplant 205, as will hereinafter be discussed.

Hollow needle 305 (FIG. 49) comprises a distal end 335, a proximal end340 and a lumen 345 extending therebetween. Distal end 335 terminates ina sharp point 350. In one preferred form of the invention, hollow needle305 comprises a side port 355 which communicates with lumen 345.

Distal implant delivery tube 310 (FIG. 50) comprises a distal end 360, aproximal end 365 and a lumen 370 extending therebetween.

Composite guidewire 315 (FIGS. 51-56) comprises a guidewire rod 370 anda guidewire sheath 380. Guidewire rod 370 comprises a distal end 385 anda proximal end 390. Distal end 385 terminates in an enlargement 395.Guidewire sheath 380 comprises a distal end 400, a proximal end 405 anda lumen 410 extending therebetween. The distal end 400 of guidewiresheath 380 comprises at least one, and preferably a plurality of,proximally-extending slits 415. Proximally-extending slits 415 open onthe distal end of guidewire sheath 380 and allow the distal end ofguidewire sheath 380 to radially expand somewhat. As will hereinafter bediscussed, guidewire rod 370 and guidewire sheath 380 are configured andsized so that guidewire rod 370 can be received in lumen 410 ofguidewire sheath 380. Furthermore, when guidewire rod 370 is forcedproximally relative to guidewire sheath 380, the proximally-extendingslits 415 in guidewire sheath 380 allow the distal end of the guidewiresheath 380 to expand somewhat so as to receive at least some of theenlargement 395 formed on the distal end of guidewire rod 370. As thisoccurs, the distal end of guidewire sheath 380 will expand radially.

Push rod 320 (FIG. 57) comprises a distal end 420, a proximal end 425and a lumen 430 extending therebetween.

Proximal implant delivery tube 330 (FIG. 58) comprises a distal end 435,a proximal end 440 and a lumen 445 extending therebetween.

Two-part occluder 200 and its associated installation apparatus arepreferably used as follows.

First, hollow needle 305 (carrying distal implant delivery tube 310therein, which in turn contains the composite guidewire 315 therein,upon which is mounted distal implant 205) is passed through the skin ofthe patient, through intervening tissue, and across the blood vessel(e.g., vein 450) which is to be occluded. See FIGS. 59-61. As this isdone, any blood flowing out side port 355 can be monitored—excessive orpulsatile blood flow can indicate that hollow needle has accidentallystruck an artery.

Next, hollow needle 305 is retracted, leaving distal implant deliverytube 310 extending across the blood vessel. See FIG. 62.

Then distal implant delivery tube 310 is retracted somewhat so as toexpose the distal ends of composite guidewire, or rod, 315 and distalimplant 205. See FIG. 63.

Next, composite guidewire 315, push rod 320 and distal implant 205 areall moved distally, so as to advance the distal ends of compositeguidewire 315 and the distal implant 205 out of the distal end of distalimplant delivery tube 310. As this occurs, legs 235 of distal implant205 are released from the constraint of distal implant delivery tube 310and expand radially. See FIGS. 64 and 65.

Then, with push rod 320 being held in place against the proximal end ofdistal implant 205, composite guidewire 315 is pulled proximally so asto bring the distal end of distal implant 205 toward the proximal end ofdistal implant 205, whereby to cause locking tangs 240 of distal implantbody 215 to enter windows 265 of distal implant locking tube 220,whereby to lock legs 235 in their radially-expanded condition (see FIG.66).

At this point, hollow needle 305, distal implant delivery tube 310 andpush rod 320 may be removed (FIG. 67), leaving distal implant 205mounted on composite guidewire 315, with the legs 235 fully deployed onthe far side of the blood vessel and the proximal end of distal implant205 extending into the interior of the blood vessel (FIG. 68).

Next, proximal implant delivery tube 330 (carrying proximal implant 210therein) is advanced down composite guidewire 315, until the distal endof proximal implant delivery tube 330 sits just proximal to the bloodvessel (FIGS. 69-72).

Then push rod 320 is used to advance the distal end of proximal implant210 out of the distal end of proximal implant delivery tube 330. As thisoccurs, legs 295 are released from the constraint of proximal implantdelivery tube 330 and open radially. See FIGS. 73-76.

Next, using push rod 320, proximal implant 210 is pushed distally asdistal implant 205 is pulled proximally using composite guidewire 315.More particularly, guidewire rod 370 is pulled proximally, which causesenlargement 395 on the distal end of guidewire rod 370 to expandguidewire sheath 380 to a size larger than lumen 262 in distal implantlocking tube 220, which causes guidewire sheath 380 to move proximally,which causes proximal movement of distal implant 205. As distal implant205 and proximal implant 210 move together, their legs 235, 295 compressthe blood vessel, thereby occluding the blood vessel. Distal implant 205and proximal implant 210 continue moving together untilinwardly-projecting tangs 300 of proximal implant 210 enter windows 245of distal implant 205, thereby locking the two members into positionrelative to one another. See FIG. 77.

At this point push rod 320 and proximal implant delivery tube 330 areremoved. See FIG. 78.

Next, composite guidewire 315 is removed. This is done by firstadvancing guidewire rod 370 distally (FIG. 79), which allows the distalend of guidewire sheath 380 to relax inwardly, thereby reducing itsouter diameter to a size smaller than lumen 262 in distal implantlocking tube 220. As a result, guidewire sheath 380 can then bewithdrawn proximally through the interior of two-part occluder 200. SeeFIG. 80. Then guidewire rod 370 can be withdrawn proximally through theinterior of two-part occluder 200. See FIG. 81.

The foregoing procedure leaves two-part occluder 200 locked in positionacross the blood vessel, with the opposing legs 235, 295 compressing theblood vessel, whereby to occlude the blood vessel.

FIGS. 83-86 illustrate another two-part occluder 200A having a distalimplant 205A and a proximal implant 210A. Two-part occluder 200A isgenerally similar to the aforementioned two-part occluder 200, exceptthat distal implant 205A utilizes a unibody construction.

FIGS. 87-90 illustrate another two-part occluder 200B. Two-part occluder200B is generally similar to the aforementioned two-part occluder 200A,except that distal implant 205B utilizes a friction fit to lock distalimplant 205B to proximal implant 210B.

FIGS. 91-94 illustrate another two-part occluder 200C having a distalimplant 205C and a proximal implant 210C. Two-part occluder 200C isgenerally similar to the aforementioned two-part occluder 200, exceptthat distal implant 205C comprises a tube 225C which receives andsecures the proximal ends of legs 235C. Legs 235C are preferablyelongated elements (e.g., bent wires) formed out of a superelastic shapememory material so as to provide the legs 235C with the desired degreeof elasticity.

FIGS. 95-100 illustrate another two-part occluder 200D having a distalimplant 205D and a proximal implant 210D. Two-part occluder 200D isgenerally similar to the aforementioned two-part occluder 200, exceptthat distal implant 205D comprises a tube or rod 225D which receives andsecures the proximal ends of legs 235D. Legs 235D are preferably coilsformed out of a superelastic shape memory material so as to provide thelegs 235D with the desired degree of elasticity.

In the foregoing disclosure, there is a disclosed a composite guidewire315 for use in delivering distal implant 205 and proximal implant 210 tothe anatomy. As noted above, composite guidewire 315 is formed from twoparts, i.e., a guidewire rod 370 and a guidewire sheath 380. Byproviding composite guidewire 315 with this two-part construction,composite guidewire 315 can have its distal diameter enlarged or reducedas desired so as to permit composite guidewire 315 to bind to distalimplant 205, or be separable from the distal implant 205, respectively.However, if desired, composite guidewire 315 can be replaced by analternative guidewire which includes a mechanism for releasably bindingthe alternative guidewire to distal implant 205. By way of example butnot limitation, such an alternative guidewire may include screw threads,and distal implant 205 may include a screw recess, so that thealternative guidewire can be selectively secured to, or released from,the distal implant 205, i.e., by a screwing action.

Looking next at FIGS. 101-104, there is shown a two-part occluder 200Eformed in accordance with the present invention. Two-part occluder 200Egenerally comprises a distal implant 205E and a proximal implant 210E.

Distal implant 205E comprises a distal implant body 215E and a distalimplant locking tube 220E. Distal implant body 215E comprises a tube225E having a distal end 226E and an opposing proximal end. Preferablydistal implant 205E has a lumen 230E extending distally from itsproximal end. Lumen 230E may extend along the entire length of distalimplant body 215E or it may terminate short of the distal end of distalimplant body 215E. By way of example but not limitation, where two-partoccluder 200E is to be set over a guidewire, lumen 230E extends alongthe entire length of distal implant body 215E. Tube 225E is slitintermediate its length so as to define a plurality of legs 235E. Distalimplant body 215E is preferably formed at least in part out of anelastic material (e.g., a shape memory material having superelasticproperties such as Nitinol or superelastic polymers, includingsuperelastic plastics) and is constructed so that its legs 235E normallyproject laterally away from the longitudinal axis of tube 225E (e.g., inthe manner shown in FIGS. 101-104), however, due to the elastic natureof the material used to form at least the legs 235E of distal implantbody 215E, legs 235E can be constrained inwardly (e.g., within the lumenof a delivery needle, as will hereinafter be discussed) so that distalimplant body 215E can assume a substantially linear disposition (inwhich case the distalmost tips of legs 235E converge to form theaforementioned proximal end of distal implant body 215E). However, whenany such constraint is removed (e.g., when distal implant body 215 is nolonger constrained within a delivery needle), the elastic nature of thematerial used to form at least the legs 235E of distal implant body 215Ecauses legs 235E to assume the position shown in FIGS. 101-104.

In one preferred form of the invention, and as seen in FIGS. 101-103,legs 235E of distal implant 205E extend at an acute angle to thelongitudinal axis of distal implant 205E, such that legs 235Ecollectively define a concave region 236E.

Distal implant locking tube 220E (FIGS. 101-104) comprises a generallytubular structure having a distal end 250E and a proximal end 260E.Preferably distal implant locking tube 220E has a lumen 262E extendingdistally from proximal end 260E. Lumen 262E may extend along the entirelength of distal implant locking tube 220E or it may terminate short ofthe distal end of distal implant locking tube 220E. By way of examplebut not limitation, where two-part occluder 200E is to be set over aguidewire, lumen 262E of distal implant locking tube 220E extends alongthe entire length of distal implant locking tube 220E. A set ofcircumferential grooves or recesses 265E are formed in distal implantlocking tube 220E, with grooves or recesses 265E being disposedintermediate distal end 250E and proximal end 260E. Distal implantlocking tube 220E also comprises a first half 266E of a mechanicalinterlock for releasably securing distal implant locking tube 220E (andhence distal implant 205E) to a distal implant delivery tube 310E (seebelow). Distal implant locking tube 220E is preferably formed out of abiocompatible material which is relatively inelastic along its length,whereby to minimize lengthwise stretching, although it may be somewhatflexible, whereby to allow it to be delivered over a curved path. By wayof example but not limitation, distal implant locking tube 220E may beformed out of a titanium alloy such as Ti 5 AL-4V.

Distal implant locking tube 220E is disposed within, and extendsproximally from, lumen 230E of distal implant body 215E. Distal implantlocking tube 220E is secured to distal implant body 215E in ways wellknown in the art (e.g., by spot welding, adhesives, mechanicalinterlocks, etc.), whereby to collectively form a singular structure(see FIGS. 101-104). Note that by forming distal implant body 215E outof an elastic material, and by forming distal implant locking tube 220Eout of a material which is relatively inelastic along its length, distalimplant body 215E is easily deformable (e.g., so that its legs 235E canbe constrained within a delivery needle) while distal implant lockingtube 220E is fixed in configuration (e.g., so that it can serve to holdproximal implant 210E to distal implant 205E, as will hereinafter bediscussed).

Still looking now at FIGS. 101-104, proximal implant 210E comprises atube 275E having a distal end, a proximal end 285E, and a lumen 290Eextending therebetween. Tube 275E is slit at its distal end so as todefine a plurality of legs 295E. A set of inwardly-projecting tangs 300Eare formed in tube 275E, between legs 295E and proximal end 285E, forengaging the aforementioned grooves or recesses 265E in distal implantlocking tube 220E, as will hereinafter be discussed (note that, ifdesired, the locations and configurations of grooves or recesses 265Eand tangs 300E can be reversed, i.e., outwardly-projecting tangs 300Ecan be provided on distal implant locking tube 220E and grooves orrecesses 265E can be provided on the inner side wall of tube 275E, orother means can be provided for connecting tube 275E of proximal implant210E to distal implant locking tube 220E of distal implant 205E).Proximal implant 210E is preferably formed at least in part out of anelastic material (e.g., a shape memory material having superelasticproperties such as Nitinol) and constructed so that its legs 295Enormally project laterally away from the longitudinal axis of tube 275E(e.g., in the manner shown in FIGS. 101-104), however, legs 295E can beconstrained inwardly (e.g., within the lumen of a delivery needle, aswill hereinafter be discussed) so that proximal implant 210E can assumea substantially linear disposition (with the distal ends of legs 295Ecollectively forming the distal end of proximal implant 210E). However,when any such constraint is removed, the elastic nature of the materialused to form at least the legs 295E of proximal implant 210E causes legs295E to return to the position shown in FIGS. 101-104.

In one preferred form of the invention, and as seen in FIGS. 101-104,legs 295E of proximal implant 210E extend at an obtuse angle to thelongitudinal axis of proximal implant 210E, such that legs 295Ecollectively define a concave region 301E.

Note that the concavity of concave region 236E of distal implant 205E isthe reverse of the concavity of concave region 301E of proximal implant210E (in other words, and as seen in FIGS. 101-104, the concavity ofconcave region 236E of distal implant 205E faces the concavity ofconcave region 301E of proximal implant 210E).

As will hereinafter be discussed, distal implant 205E and proximalimplant 210E are configured and sized so that distal implant lockingtube 220E of distal implant 205E can be received in lumen 290E ofproximal implant 210E, with the expanded legs 235E of distal implant205E opposing the expanded legs 295E of proximal implant 210E (see, forexample, FIGS. 103 and 104), whereby to impose a clamping action on theside walls of a blood vessel (e.g., vein) disposed therebetween andthereby occlude the blood vessel, as will hereinafter be discussed infurther detail (or, as an alternative, the opposing expanded legs of theproximal and distal implants may interdigitate so as to further enhancethe clamping action. Furthermore, distal implant 205E and proximalimplant 210E are configured and sized so that they may be locked in thisposition, inasmuch as inwardly-projecting tangs 300E of proximal implant210E will project into circumferential grooves or recesses 265E ofdistal implant locking tube 220E of distal implant 205E, whereby tosecure proximal implant 210E to distal implant 205E. Note that thepositions of circumferential grooves or recesses 265E of distal implantlocking tube 220E and inwardly-projecting tangs 300E of proximal implant210E are coordinated so that when inwardly-projecting tangs 300E ofproximal implant 210E are disposed in circumferential grooves orrecesses 265E of distal implant locking tube 220E, legs 235E of distalimplant 205E and legs 295E of proximal implant 210E are sufficientlyclose to ensure adequate clamping of a blood vessel (or other tubularstructure) disposed therebetween.

Two-part occluder 200E is intended to be deployed using associatedinstallation apparatus. In one preferred form of the invention, suchassociated installation apparatus preferably comprises a hollow needle305E (FIG. 109) for penetrating tissue, a distal implant delivery tube310E (FIG. 110) for delivering distal implant 205E through hollow needle305E to the far side of the blood vessel (or other tubular structure)which is to be occluded, and a proximal implant delivery tube 330E (FIG.110) for delivering proximal implant 210E for mating with distal implant205E, as will hereinafter be discussed.

If desired, the associated installation apparatus may be provided in theform of a laparoscopic device 331E as shown in FIGS. 105-113.Laparoscopic device 331E comprises a handle 332E, an outer sheath 333E,a knob 334E, a first trigger 336E, a second trigger 337E and a releaselever 338E, with the functionality hereinafter described.

More particularly, hollow needle 305E (FIG. 109) comprises a distal end335E, a proximal end (not shown, but contained within laparoscopicdevice 331E) and a lumen 345E extending therebetween. Distal end 335E ofhollow needle 305E terminates in a sharp point 350E.

Distal implant delivery tube 310E (FIG. 110) comprises a distal end 360Eand a proximal end (not shown, but contained within laparoscopic device331E). Distal end 360E of distal implant delivery tube 310E alsocomprises a second half 361E of a mechanical interlock for releasablysecuring the distal end of distal implant delivery tube 310E to theproximal end of distal implant 205E, i.e., by the releasableinterconnection of the first half 266E of the mechanical interlock(carried by the proximal end of distal implant locking tube 220E) withthe second half 361E of the mechanical interlock (carried by the distalend of distal implant delivery tube 310E).

Proximal implant delivery tube 330E (FIG. 110) comprises a distal end435E, a proximal end (not shown, but contained within laparoscopicdevice 331E) and a lumen 445E extending therebetween.

Two-part occluder 200E and its associated installation apparatus (e.g.,laparoscopic device 331E) are preferably used as follows.

First, hollow needle 305E is passed to the occlusion site, preferablywhile needle 305E is contained within sheath 333E of laparoscopic device331E (FIG. 107). Then sheath 333E is retracted, e.g., by turning knob334E (FIG. 108), and hollow needle 305E is passed across the bloodvessel (e.g., a vein) which is to be occluded (or passed across anothertubular structure which is to be occluded, or passed through tissue orobjects to be secured to one another, such as a solid organ, or layersof tissue, etc.).

Next, hollow needle 305E is retracted proximally, back across the bloodvessel, e.g., via first trigger 336E (FIG. 109). This action allows legs235E of distal implant 205E to expand radially on the far side of theblood vessel. At this point, distal implant locking tube 220E extendsproximally through the blood vessel.

Then, with distal implant delivery tube 310E held in place via distalimplant delivery tube 310E and its interlock with distal implant lockingtube 220E (and hence distal implant 205), hollow needle 305E iswithdrawn further proximally (e.g., via first trigger 336E) untilproximal implant 210E is no longer constrained within hollow needle 305E(FIG. 110). As this occurs, legs 295E of proximal implant 210E arereleased from the constraint of hollow needle 305E and open radially.

Proximal implant delivery tube 330E is then advanced distally, e.g.,using second trigger 337E, until proximal implant 210E and distalimplant 205E come together (FIG. 111). As distal implant 205E andproximal implant 210E move together, their legs 235E, 295E compress theblood vessel therebetween, thereby occluding the blood vessel. Distalimplant 205E and proximal implant 210E continue moving together untilinwardly-projecting tangs 300E of proximal implant 210E entercircumferential grooves or recesses 245E of distal implant 205E, therebylocking the two members into position relative to one another.

At this point, proximal implant delivery tube 330E is withdrawn (FIG.112), distal implant delivery tube 310E is released from distal implant205E (i.e., by using lever 338E to unlock the second half 361E of themechanical interlock (carried by the distal end of distal implantdelivery tube 310E) from the first half 266E of the mechanical interlock(carried by the proximal end of distal implant locking tube 220E), andthen the installation device is withdrawn (FIG. 113).

The foregoing procedure leaves two-part occluder 200E locked in positionacross the blood vessel, with the opposing legs 235E, 295E compressingthe blood vessel therebetween, whereby to occlude the blood vessel.

In the preceding disclosure, two-part occluder 200E is discussed in thecontext of using the elasticity of its legs 235E, 295E to cause its legs235E, 295E to reconfigure from a diametrically-reduced configuration(e.g., when constrained within a delivery needle) to adiametrically-expanded configuration (e.g., when released from theconstraint of a delivery needle). However, it should also be appreciatedthat where legs 235E, 295E are formed out of a shape memory material(e.g., Nitinol), a temperature change may be used to reconfigure legs235E, 295E from a diametrically-reduced configuration to adiametrically-expanded configuration. By way of example but notlimitation, in this form of the invention, legs 235E, 295E may beconstructed so as to have a diametrically-reduced configuration whenmaintained at a temperature below body temperature, and legs 235E, 295Emay be constructed so as to have a diametrically-expanded configurationwhen maintained at body temperature. As a result, by cooling two-partoccluder 200E to a temperature below body temperature, inserting thetwo-part occluder into the body, and then allowing the two-part occluderto heat to body temperature, legs 235E, 295E can be caused toreconfigure from their diametrically-reduced configuration to adiametrically-expanded configuration.

FIGS. 114-120 show an alternative form of installation device. Moreparticularly, FIGS. 114-120 show another laparoscopic device 331E. Thelaparoscopic device 331E shown in FIGS. 114-120 is generally similar tothe laparoscopic device 331E shown in FIGS. 105-113, except that secondtrigger 337E is omitted, and lever 338E is used to both: (i) advanceproximal implant delivery tube 330E until proximal implant 210E anddistal implant 205E come together (FIG. 119), and (ii) release distalimplant 205E from distal implant locking tube 220E (FIG. 120) (i.e., byunlocking the second half 361E of the mechanical interlock (carried bythe distal end of distal implant delivery tube 310E) from the first half266E of the mechanical interlock (carried by the proximal end of distalimplant locking tube 220E)).

FIGS. 121-123 show another two-part occluder 200E also formed inaccordance with the present invention. The occluder 200E shown in FIGS.121-123 is substantially the same as the occluder 200E shown in FIGS.101-120, except that legs 235E of distal implant 205E, and legs 295E ofproximal implant 210E, have their concavity directed in the samedirection, so that legs 235E, 295E nest with one another rather thanconfront one another. In addition, as seen in FIGS. 121-123, tube 225Eof distal implant 205E is partially received in lumen 290E of proximalimplant 210E.

FIGS. 124-126 show one preferred construction for releasably securingdistal implant 205E of the two-part occluder 200E of FIGS. 121-123 todistal implant delivery tube 310E. More particularly, in this form ofthe invention, and looking now at FIGS. 124-126, the first half 266E ofthe mechanical interlock (carried by the proximal end of distal implantlocking tube 220E) comprises a stepped configuration 433E, and thesecond half 361E of the mechanical interlock (carried by the distal endof distal implant delivery tube 360E) comprises another steppedconfiguration 434E, wherein stepped configuration 433E and steppedconfiguration 434E are inverses of one another so as to mate together.After the second half 361E of the mechanical interlock (carried by thedistal end of distal implant delivery tube 310E) has been secured to thefirst half 266E of the mechanical interlock (carried by the proximal endof distal implant locking tube 220E), the connection between distalimplant delivery tube 310E and distal implant 205E can be enhanced,e.g., by telescopically projecting a locking rod 436E out of a centrallumen 437E of distal implant delivery tube 310E and into lumen 262E ofimplant locking tube 220E. In this form of the invention, theinstallation device (e.g., laparoscopic device 331E of FIGS. 105-113, orlaparoscopic device 331E of FIGS. 114-120) include appropriate controlmeans (e.g., release lever 338E) for telescopically moving locking rod436E out of central lumen 437E of distal implant delivery tube 310E andinto lumen 262E of implant locking tube 220E. Alternatively, in anotherform of the invention, internal locking rod 436E may be replaced by anovertube (not shown) which telescopically projects over distal implantdelivery tube 310E and distal implant locking tube 220E of distalimplant 205E, whereby to enhance the connection between the members.

It should also be appreciated that other forms of mechanical interlocksmay be used for releasably securing distal implant 205E of the two-partoccluder 200E of FIGS. 121-123 to distal implant delivery tube 310E. Byway of example but not limitation, a screw interlock may be used, e.g.,the first half 266E of the mechanical interlock (carried by the proximalend of distal implant locking tube 220E) may comprise a threaded bore,and the second half 361E of the mechanical interlock (carried by thedistal end of distal implant delivery tube 360E) may comprise a threadedpost, wherein the threaded post carried by the distal end of distalimplant delivery tube 360E may be received in the threaded bore ofdistal implant locking tube 220E. Alternatively, other configurations ofa screw interlock may be used, or other forms of mechanical interlocksmay be used.

In the constructions shown in FIGS. 101-143, a mechanical interlock(e.g., a first half 266E carried by the proximal end of distal implantlocking tube 220E and a second half 361E carried by the distal end ofdistal implant delivery tube 310E) is used to connect distal implantlocking tube 220E (and hence distal implant 205E) to distal implantdelivery tube 310E. Alternatively, if desired, distal implant lockingtube 220E can be formed integral with distal implant delivery tube 310E,with a weakened section disposed at their intersection, and the twomembers separated by a mechanical breaking action.

It will be appreciated that, in certain circumstances, it may bedesirable to increase the surface area of those portions of the occluderwhich contact the tubular structure, in order to better distribute theload applied to the tissue. In this situation, it can be helpful toincrease the width of the legs (e.g., legs 235E and/or legs 295E oftwo-part occluder 205E, etc.), and/or to provide flexible material inthe zone between adjacent legs (e.g., in the manner of an umbrella) sothat the flexible material can also carry load (i.e., essentiallyincreasing the effective width of legs 235E and/or legs 295E). See, forexample, FIG. 127, which shows flexible material 438E extending betweenlegs 235E and legs 295E.

FIGS. 128-133 show a placement device 500 for the facilitating properplacement of the occluder (e.g., the two-part occluder 200E) so as toocclude a blood vessel (or other hollow tubular body). Placement device500 generally comprises a blood vessel locator needle 505, which is aneedle of relatively small diameter (e.g., 21 gauge or smaller), and aguiding component 510 (which may be manufactured from an inexpensivematerial such as plastic). Guiding component 510 includes a seat 515 forreceiving blood vessel locator needle 505, and an opening 520 forslidably accommodating the shaft of an installation device for settingthe occluder (e.g., laparoscopic device 331E of FIGS. 105-113, orlaparoscopic device 331E of FIGS. 114-120, etc.).

In use, blood vessel locator needle 505 is positioned in seat 515 ofguiding component 510, and then the blood vessel locator needle 505 isadvanced through the target blood vessel (e.g., under ultrasoundguidance). See FIG. 129. Proper placement of blood vessel locator needle505 is confirmed as blood begins to flow out the proximal end of bloodvessel locator needle 505. Next, the shaft of the installation devicefor setting the occluder (e.g., laparoscopic device 331E of FIGS.105-113, or laparoscopic device 331E of FIGS. 114-120, etc.) is advancedthrough opening 520 of guiding component 510. See FIG. 130. Advancementoccurs until a stop 525 on the shaft of the installation device engagesthe proximal end of guiding component 510. See FIG. 131. When stop 525on the shaft of the installation device engages the proximal end ofguiding component 510, the distal end of the shaft of the installationdevice will have passed through the target blood vessel. See FIG. 132.At this point, blood vessel locator needle 505 is withdrawn (see FIG.133) and deployment of the occluder proceeds as previously discussed.

It will be appreciated that, in certain circumstances, the blood vessel(or other tubular structure) to be occluded may be positioned close toan underlying anatomical structure, e.g., an organ, a nerve, anothertubular structure, etc. In this situation, it may be helpful to lift theblood vessel (or other tubular structure) upward, away from theunderlying anatomical structure, so that the sharp distal tip of thedeployment needle does not engage the underlying anatomical structure,and so that the distal end of the occluder (e.g., distal implant 205E oftwo-part occluder 200E) does not engage the underlying anatomicalstructure, since any such engagement with the underlying anatomicalstructure could cause trauma to the underlying anatomical structure. Tothat end, and looking now at FIG. 134, clamping forceps 530 (or othertool having a bifurcated distal end) may be placed between the bloodvessel (or other tubular structure) and the underlying anatomicalstructure, and then pulled upwardly, away from the underlying anatomicalstructure, so as to separate the target blood vessel (or other tubularstructure or tissue) from the underlying anatomical structure. Theoccluder (e.g., two-part occluder 200E) may then be safely passedthrough the target blood vessel (or other tubular structure), passingbetween the bifurcated distal end of the tool, and deployed aspreviously discussed.

Using the Occluder to Occlude Tubular Structures Other than BloodVessels

It will be appreciated that the occluder of the present invention canalso be used to occlude tubular structures other than blood vessels. Byway of example but not limitation, the temporary occluder of the presentinvention can be used to occlude other structures within the body (e.g.,tubes such as fallopian tubes and/or vas deferens for temporary orpermanent sterilization, ducts such as bile ducts and cystic ducts forcholecystectomy, lymphatic vessels, including the thoracic duct, fistulatracts, etc.).

Using the Occluder to Close Openings in Structures and/or for Securingat Least Two Objects Together

In the foregoing disclosure, the occluder is discussed in the context ofoccluding a tubular structure (e.g., a blood vessel, fallopian tubes,lymphatic vessels, etc.) by clamping together opposing side walls of thetubular structure in order to occlude the tubular structure. In such anapplication, the occluder effectively secures one side wall of thetubular structure to the opposing side wall of the tubular structure.However, it should also be appreciated that the occluder of the presentinvention may be used to close openings in structures and/or to securetwo or more objects together for other applications.

By way of example but not limitation, the occluder of the presentinvention may be used to secure two or more portions of tissue togetherso as to close an incision.

By way of further example but not limitation, the occluder of thepresent invention may be used in a “stomach stapling” procedure to bringtogether opposing side walls of the stomach in order to reduce the sizeof the stomach.

Furthermore, the occluder of the present invention may be used in anorgan resection (e.g., a liver resection), so as to seal the peripheryof the resected organ.

By way of further example but not limitation, and looking now at FIGS.135-137, the occluder of the present invention can be used forselectively clamping or occluding regions of solid organs so as toselectively stop blood flow or blood loss in various regions throughtissue compression. The occluder may be used in solid organ resection ofthe kidney or liver or other organs. Blood loss and secretion leakage(e.g., bile, urine, etc.) can be problematic in existing solid organresection procedures. Average blood loss for a liver resection is700-1200 ml. By clamping desired regions of the solid organ with theoccluder of the present invention, it is possible to significantlyreduce the amount of undesirable fluid loss (blood loss, secretionleakage, etc.). The occluder of the present invention, can be used toapply pressure selectively to broad areas of the organ and,additionally, may also be used to close off selective tubular structuresand vessels connecting the organ with other regions of the body. In oneembodiment and method, multiple discrete occluder elements may beindividually, selectively deployed across regions of the organ. See, forexample, FIG. 135, which shows multiple, single, separate punctureplacements of the occluder for closing off a resected liver. Note thatwhere multiple, single, separate puncture placements of the occluder areused, different regions of the solid organ may be compressed todifferent and controllable degrees.

In a novel embodiment of the present invention, the length of distalimplant locking tube 220E (of distal implant 205E) remaining in the bodycan be determined once clamping of the occluder has been effected, byproviding distal implant locking tube 220E and/or distal implantdelivery tube 310E with weakened (e.g., frangible) sections, and bybreaking off distal implant locking tube 220E from distal implantdelivery tube 310E at a region above proximal implant 210E. This breakcan be achieved by incorporating selective weakened regions into thedistal implant locking tube 220E and/or distal implant delivery tube310E, so that when a selective weakened region is subjected to twists,or torques, or bending, or pulling, or selective other strains orstresses or the like, distal implant locking tube 220E will separatefrom distal implant delivery tube 310E at a location proximal toproximal implant 210E. Because clamping is effected across the tissue,distal implant locking tube 220E connecting distal implant body 215 andproximal implant 210E will not move, while distal implant delivery tube310E will disconnect from distal implant locking tube 220E. Distalimplant locking tube 220E, which connects distal implant body 215E andproximal implant 210E, may be solid or flexible.

In other embodiments of the present invention, distal implant lockingtube 220E may be composed of multiple interlocking sections, andconstrained by an encasing sheath, or once deployed, by the surroundingtissue. Once clamping of the tissue is achieved, the sheath can beretracted beyond the proximal implant, exposing an interlocking regionbetween the distal implant locking tube 220E sections and then, with atwist, or appropriate unlocking mechanism, enable the occluder to bedisconnected from the distal implant delivery tube 310E.

This construction enables the clamping distance between distal implant205E and proximal implant 210E to be controllable, and allows forsignificant tissue thicknesses to be clamped.

In the embodiment shown in FIG. 136, the occluders are delivered inconjunction with single or multiple compression bands 550, which may bepolymers, or other tissue material or metals or other commonly usedmaterials known in the art. The compression bands 550 may be rolled intothe delivery needle or sheath and unfurled prior to delivery of theoccluders. The compression bands 550 extend the pressure across abroader region of the organ or tissue which receives the occluders ofthe present invention.

In other embodiments, the legs of the occluder may have a thin metallicor polymeric mesh or film that is flexible, yet connects between thefingers, to enable further distribution of pressure on a clamped tissue,vessel, organ or the like.

In the embodiment of FIG. 137, multiple occluders can be delivered inparallel to an organ, tissue, tubular structure or the like. In thisform of the invention, an installation device 555, comprising a body 560having a plurality of deployment needles 565 extending therefrom, can beused for setting the multiple occluders. Installation device 555 candeliver either single occluders deployed one at a time, but in aspatially-constrained way, with a pre-defined spacing between theoccluders (determined by the predefined spacing between deploymentneedles 565), or can deliver a plurality of occluders all at the sametime, with a single activation control. This construction can reduce theamount of time required for a procedure such as a resection, byproviding for simultaneous occluder deployments.

In other embodiments of the present invention, the occluders can bedeployed across multiple tissues, or multiple folds of the same tissue,organ or tubular structure. In certain embodiments of the presentinvention, the distal implant locking tube 220E may be elastic, allowingfor some movement of the clamped tissue, while still maintaining adesired clamping force or pressure on the tissue.

The occluders of the above invention may also be used for bariatricsurgery, or to reduce or plicate the stomach, or to create a gastrostomysleeve.

In another embodiment of the present invention, the unreleased distalimplant 205E can be used as the retractor, and retract the tissue awayfrom any organs or tissues or major blood vessel beneath, enablingsubsequent deployment of other occluders to be placed in a manner thatmay enable reduction of the size of an organ, joining organs together,closing a tear in the bowel or the like. Once the other desiredoccluders have been deployed, the deployment of the first occluder(i.e., unification of the proximal implant 210E with the distal occluder205E) can be completed.

Use of the Invention Under Direct Visualization and/or IndirectVisualization

Significantly, the present invention may be practiced under directvisualization (e.g., during “open” surgery) or under indirectvisualization (e.g., during laparoscopic surgery where visualization isprovided through the use of a scope, or during percutaneous surgerywhere visualization is provided through the use of imaging apparatussuch as an ultrasound imager, an X-ray imager, etc.).

MODIFICATIONS OF THE PREFERRED EMBODIMENTS

It should be understood that many additional changes in the details,materials (e.g., shape memory polymers that are permanent or thatdissolve over time, or carbon nanotube based), steps and arrangements ofparts, which have been herein described and illustrated in order toexplain the nature of the present invention, may be made by thoseskilled in the art while still remaining within the principles and scopeof the invention.

What is claimed is:
 1. Apparatus for occluding a space between a first structure and a second structure, said apparatus comprising: an occluder, said occluder comprising a distal implant and a proximal implant, wherein: said distal implant comprises a body and a locking shaft mounted to said body, wherein said body of said distal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the first structure, and further wherein said locking shaft comprises a first locking element for selective connection to said proximal implant and a second locking element for selective connection to an inserter for deploying said occluder; and said proximal implant comprises a body having an opening, wherein said body of said proximal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the second structure, and further wherein said body of said proximal implant comprises a third locking element for selective connection to said first locking element of said distal implant; wherein said locking shaft of said distal implant is slidably receivable within said opening in said body of said proximal implant, and further wherein said first locking element of said distal implant and said third locking element of said proximal implant are selectively engagable with one another so as to hold said distal implant and said proximal implant in fixed position relative to one another.
 2. Apparatus according to claim 1 wherein said locking shaft of said distal implant is formed out of a first material and said body of said distal implant is formed out of a second, different material.
 3. Apparatus according to claim 2 wherein said locking shaft of said distal implant is formed out of a titanium alloy.
 4. Apparatus according to claim 3 wherein said titanium alloy comprises Ti 5 AL-4V.
 5. Apparatus according to claim 2 wherein said body of said distal implant is formed out of a shape memory alloy.
 6. Apparatus according to claim 5 wherein said shape memory alloy comprises Nitinol.
 7. Apparatus according to claim 1 wherein said body of said proximal implant is formed out of a shape memory alloy.
 8. Apparatus according to claim 7 wherein said shape memory alloy comprises Nitinol.
 9. Apparatus according to claim 1 further comprising an inserter, wherein said inserter comprises a fourth locking element for selective connection to said second locking element of said distal implant.
 10. Apparatus according to claim 9 wherein said second locking element of said distal implant comprises a stepped configuration and said fourth locking element of said inserter comprises an inverse stepped configuration.
 11. Apparatus according to claim 9 wherein said second locking element of said distal implant comprises one of a threaded bore and a threaded post and said fourth locking element of said inserter comprises the other of a threaded bore and a threaded post.
 12. Apparatus according to claim 1 wherein said locking shaft of said distal implant includes a lumen.
 13. Apparatus according to claim 12 wherein said lumen extends completely through said locking shaft of said distal implant.
 14. Apparatus according to claim 12 further comprising an inserter, and further wherein said inserter comprises a lumen which is aligned with said lumen formed in said locking shaft of said distal implant.
 15. Apparatus according to claim 14 further comprising a rod telescopically projectable out of said lumen of said inserter and into said lumen of said locking shaft of said distal implant.
 16. Apparatus according to claim 1 wherein said first locking element of said locking shaft of said distal implant comprises one of a male member and a female recess, and further wherein said third locking element of said proximal implant comprises the other of a male member and a female recess.
 17. Apparatus according to claim 1 wherein said plurality of legs of said distal implant have a concave configuration, and further wherein said plurality of legs of said proximal implant have a concave configuration.
 18. Apparatus according to claim 17 wherein said concave configuration of said plurality of legs of said distal implant confronts, in opposing relation, said concave configuration of said plurality of legs of said proximal implant.
 19. Apparatus according to claim 17 wherein said concave configuration of said plurality of legs of said distal implant nests within said concave configuration of said plurality of legs of said proximal implant.
 20. Apparatus according to claim 1 wherein material is disposed between said plurality of legs of said distal implant, and further wherein material is disposed between said plurality of legs of said proximal implant.
 21. A method for occluding a space between a first structure and a second structure, said method comprising: providing apparatus comprising: an occluder, said occluder comprising a distal implant and a proximal implant, wherein: said distal implant comprises a body and a locking shaft mounted to said body, wherein said body of said distal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the first structure, and further wherein said locking shaft comprises a first locking element for selective connection to said proximal implant and a second locking element for selective connection to an inserter for deploying said occluder; and said proximal implant comprises a body having an opening, wherein said body of said proximal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the second structure, and further wherein said body of said proximal implant comprises a third locking element for selective connection to said first locking element of said distal implant; wherein said locking shaft of said distal implant is slidably receivable within said opening in said body of said proximal implant, and further wherein said first locking element of said distal implant and said third locking element of said proximal implant are selectively engagable with one another so as to hold said distal implant and said proximal implant in fixed position relative to one another; and positioning said occluder so that said plurality of legs of said distal implant are disposed against the first structure, said plurality of legs of said proximal implant are disposed against the second structure, and said locking shaft extends across the space between the first structure and the second structure.
 22. A method according to claim 21 wherein positioning said occluder comprises: advancing said distal implant through the second structure and through the first structure; and moving at least one of said proximal implant and said distal implant toward the other of said proximal implant and said distal implant so that the first structure and the second structure are forced together.
 23. A method according to claim 22 wherein at least one of said proximal implant and said distal implant is moved toward the other of said proximal implant and said distal implant until said first locking element and said third locking element engage one another.
 24. A method according to claim 21 wherein the said first structure comprises a first portion of the side wall of a hollow structure and said second structure comprises a second portion of the side wall of the hollow structure.
 25. A method according to claim 24 wherein the hollow structure comprises a blood vessel.
 26. A method according to claim 21 wherein the first structure comprises an outer surface of an object and the second structure comprises an outer surface of another object.
 27. A method according to claim 21 wherein the first structure comprises an outer surface of an organ and the second structure comprises another outer surface of the same organ. 